RELUGOLIX - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for relugolix and what is the scope of patent protection?
Relugolix
is the generic ingredient in one branded drug marketed by Sumitomo Pharma and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Relugolix has one hundred and fifty-nine patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for RELUGOLIX
International Patents: | 159 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Clinical Trials: | 26 |
Patent Applications: | 225 |
What excipients (inactive ingredients) are in RELUGOLIX? | RELUGOLIX excipients list |
DailyMed Link: | RELUGOLIX at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RELUGOLIX
Generic Entry Date for RELUGOLIX*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for RELUGOLIX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Prostate Cancer Foundation | Phase 2 |
Pfizer | Phase 2 |
Dana-Farber Cancer Institute | Phase 2 |
Pharmacology for RELUGOLIX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sumitomo Pharma | ORGOVYX | relugolix | TABLET;ORAL | 214621-001 | Dec 18, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for RELUGOLIX
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Accord Healthcare S.L.U. | Orgovyx | relugolix | EMEA/H/C/005353 Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer. |
Authorised | no | no | no | 2022-04-29 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for RELUGOLIX
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | 3415517 | ⤷ Try a Trial | |
Canada | 3038875 | TRAITEMENT DU CANCER DE LA PROSTATE (TREATMENT OF PROSTATE CANCER) | ⤷ Try a Trial |
New Zealand | 735026 | Solid preparations of n-(4-(1-(2,6-difluorobenzyl)-5-((dimethyl amino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidine-6-yl)phenyl)-n’-methoxyurea or a salt thereof, and methods of preparing same | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2014051164 | ⤷ Try a Trial | |
Spain | 2724206 | ⤷ Try a Trial | |
Japan | WO2016136849 | 固形製剤 | ⤷ Try a Trial |
Mexico | 2019003733 | TRATAMIENTO DE CANCER DE PROSTATA. (TREATMENT OF PROSTATE CANCER.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RELUGOLIX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1591446 | 21C1056 | France | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1565 20210720 |
1591446 | 2022C/501 | Belgium | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1565 20210720 |
1591446 | 301158 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1565 20210720 |
1591446 | 2190051-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REG. NO/DATE: EU/1/21/1565 20210720 |
1591446 | 122022000002 | Germany | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1565 20210716 |
1591446 | SPC/GB21/065 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX OR A SALT THEREOF; REGISTERED: UK EU/1/21/1565(NI) 20210720; UK FURTHER MA ON IPSUM 20210720 |
1591446 | C202130069 | Spain | ⤷ Try a Trial | PRODUCT NAME: RELUGOLIX O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1565; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1565; DATE OF FIRST AUTHORISATION IN EEA: 20210716 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.